Powerful Leader Takes Command of a Battered FDA: Irresistible Force Meets Immovable Object

Margaret Hamburg, long admired as a strong leader who has tackled and solved public health problems that others shunned, was confirmed on May 18 as the new head of the U.S. Food and Drug Administration, an agency in trouble.

The FDA’s failures are well known. Peanuts and other foods infected with salmonella. Poisonous heparin from China. [1] Vioxx taken off the market after it caused heart damage in an estimated tens of thousands of patients.[2] Cardiac defibrillators that suddenly failed.[3] Filthy syringes containing deadly bacteria.[4]

For decades there has never been a quiet period when the American public could rest easy, able to count on the safety of products regulated by the FDA.

Whose fault? The obvious culprit is the FDA itself. The New York Times said in a January editorial that the FDA has been “justly pilloried for grievous flaws in its regulation of foods and drugs” and is “ready for a major overhaul.”[5]

But it’s not that simple. Outside the FDA there are government officials who bear much of the blame. Members of Congress and policy‑makers in the White House have kept the FDA on a starvation budget for many years. In addition, some of them have put business interests ahead of the public interest and pressured the FDA to take risky shortcuts in approving medical products. Lobbyists and campaign contributors have benefited from their influence over the FDA. Clearly the FDA alone is not to blame for its present plight.

Dr. Hamburg, the new FDA Commissioner, has an outstanding record as an expert on public health and an administrator with political savvy. If anyone can fix the FDA, she and her new deputy, Joshua Sharfstein, may be the ones to do it.

Dr. Hamburg’s views and activism fit well with those of the Obama administration. She is likely to have the administration’s strong backing in most of what she wants to undertake. Furthermore, in the May 7 committee hearing on her confirmation, both Democratic and Republican senators expressed their strong support for her, and on May 18 the full Senate confirmed her as Commissioner by apparently unanimous voice vote. With this broad bipartisan support and through her own prowess, she will undoubtedly solve or mitigate some of the FDA’s problems.

However, Dr. Hamburg may be unable to overcome the FDA’s most widely criticized shortcomings. We believe that lapses in food and drug safety – like those listed at the start of this article – will probably continue. The ability of the FDA to prevent these calamities is unlikely to improve much in the new few years.

There are several reasons for this pessimism.

Budget

A huge budget increase – a doubling or tripling in the next few years – is long overdue. Demands on the FDA’s resources, especially on its overburdened scientific personnel, have been skyrocketing.

The FDA is unable to cope with the flood of imported food and drugs entering the U.S.. Inspectors can examine only a tiny fraction of these products, and inspections are often perfunctory. Some exporting countries can’t possibly ensure the safety of the food and drugs they ship to the U.S. Poisonous heparin is one example of a product that should have been caught, either in China or the U.S., and kept off the market. More FDA inspectors are needed for the surveillance of imported and domestic products. More FDA resources are also needed to help educate and monitor countries, such as China, with weaker safeguards than ours for the food, drugs, and devices that they export to the U.S.

The FDA’s total annual budget is about $2.3 billion. For comparison, the National Institutes of Health has a budget more than ten times as large. In February 2008 a panel of experts (a subcommittee of the FDA Science Board) recommended that the taxpayers’ share of the FDA budget be raised from $1.5 billion in 2008 to $3.7 billion in 2013.[6] Congress has granted increases since then, but not nearly as much as was recommended. The number of new personnel hired has also fallen short.

Moreover, the FDA depends in part on “user fees” of about $550 million annually.[7] These are direct payments by manufacturers for certain services provided to them by the FDA. In return, the manufacturers count on special consideration, including faster approvals of drugs and devices. Often “faster” means “less careful” or “less independent.” POGO believes that the FDA’s approval process should be entirely a government responsibility and that its cost should be covered fully by the government. This seems unlikely to happen, and in fact the trend in user fees is upward.

Dr. Hamburg presumably knows what’s needed to rescue the FDA from its desperate budgetary predicament. But her considerable powers of persuasion may not succeed when the White House prepares its FDA budget proposal for 2011.[8] Afterwards, if there are episodes in which the public health is endangered by an unsafe food, drug, or device, Dr. Hamburg will probably be summoned by the Congress and asked to explain.

For years the Congress has failed to throw its weight behind the huge budget increases needed to strengthen the FDA’s regulatory powers. At present most medications and medical devices pass fairly quickly through the FDA’s complex, multi‑step approval process. Some of these products later cause harm to the public and are found to be defective.

Some of the unsafe medications and devices would be kept off the market if there were better pre‑market examination by a well‑staffed FDA. However, tighter regulation would inevitably lead to rejections and delays that could cost manufacturers billions of dollars. Closer scrutiny by the FDA and tighter regulation are abhorrent to some manufacturers, who fear that stronger FDA will curb their prerogatives and profits. Some Members of Congress have similar reservations.

Later this year, after debating the size of the FDA budget, Congress will vote on the actual appropriation for 2010. We’ll soon learn if next year’s FDA budget reflects the huge increases that were recommended 15 months ago.

Improper Influence

Last month a group of FDA scientists excoriated FDA managers for caving in to pressure from businesses and Members of Congress. The managers, they wrote, gave their stamp of approval to questionable products regarded as unsafe by some of the FDA scientists most familiar with the products. In their April 2, 2009, letter to President Obama,[9] these whistleblowers (whose names were redacted from the online copy) cited specific examples that have also been described in detail in the press. The Wall Street Journal, for example, wrote in January about a Senator and two Representatives who contacted the FDA on behalf of a medical device manufacturer in their home state of New Jersey.[10] They asked the then‑Commissioner of the FDA to review the issue personally.

Eventually top officials at the FDA approved the device (used for surgical treatment of knee injuries), but only over the opposition of FDA scientists who doubted the claims of its manufacturer. One of the epresentatives was quoted as saying, “Our effort to help [the company] was solely to ensure they received a fair and unbiased FDA review.” It’s possible this is an accurate description of the Congress Members’ motives. On the other hand, a statement like this is the standard disclaimer to the effect that there was no intention to exert congressional pressure improperly – a claim impossible to verify or refute.

Dr. Hamburg will find it hard to rein in the questionable influence by outsiders over her agency’s decisions. The various forms of influence are so widespread and ingrained that honest politicians may not know where to draw the line. Some FDA managers may by now be accustomed to complying almost automatically with the wishes of Members of Congress.

Questionable attempts to sway the FDA are generally invisible to the public and difficult for reporters to discover. A possible remedy is increased transparency – a practice consistent with the goals of the current administration. Almost all communications between Members of Congress and FDA personnel could be made public by default. Routine public disclosure of congressional contacts might at least help define the problem, even if it doesn’t correct it. Other sorts of communications would also benefit from increased transparency, namely, those the FDA receives from manufacturers by phone, in writing, and in person. However, Dr. Hamburg may lack the authority, as FDA Commissioner, to require these various disclosures.

Treatment of Whistleblowers

In their April 2 letter to the President, the whistleblowers wrote about “systemic corruption and wrongdoing” within the FDA. They also reported job‑related retaliation as a routine response to whistleblowers’ efforts to speak out about these issues.

In her nomination hearing before a Senate committee on May 7, Dr. Hamburg said that government whistleblowers serve an important role in bringing out critical issues and making sure they are addressed.[11] She evidently recognizes that whistleblowers are indispensable to any large organization that genuinely seeks to correct its internal problems. But will she just try to get things right in the future (as the President has said in another context) instead of looking at what was wrong in the past?

We at POGO believe that Dr. Hamburg’s first step should be to investigate whistleblowers’ unresolved complaints. She and the agency legal staff should deal fully with allegations of past and ongoing wrongdoing. They should make sure that the harm to whistleblowers previously caused by retaliation is neutralized and reversed and that those shown to be wrongdoers are dismissed or otherwise disciplined. If she doesn’t do this, it will be hard for FDA staff to take seriously any promise that from this time forward, whistleblowers can feel confident that their allegations will be judged fairly and acted upon promptly and that there will be no retaliation.

Conclusion

The problems described in this article would be hard to resolve even under ideal circumstances. But we believe that the FDA’s resources will continue to lag behind its needs and that Dr. Hamburg will be handicapped by constraints on her authority.

In particular, it’s likely that the FDA will remain underfunded, that politicians and manufacturers will keep pressuring the FDA improperly, to the detriment of the public, and that valid criticisms by whistleblowers and other FDA scientists will be ignored. Serious lapses in food and drug safety – such as those listed at the start of this article – will probably continue.

A turnaround is possible. The new Commissioner has a heavy burden of public health responsibilities, including preparations for a flu pandemic. But she also has strong allies in the White House, the Congress and the FDA itself. Under her leadership the FDA may finally start to protect the American public as it should.

____________________________________

[1] Edelson, Ed. "Report Confirms Source of Contaminated Heparin." The Washington Post, December 3, 2008.

[2] Graham, David J., David Campen, Rita Hui, Michele Spence, Craig Cheetham, Gerald Levy, Stanford Shoor, and Wayne A. Ray. "Risk of acute myocardial infarction and sudden cardiac death in patients treated with cyclo-oxygenase 2 selective and non-selective non-steroidal anti-inflammatory drugs: nested case-control study." Lancet, vol. 365, February 5, 2005, pp. 475-481.

[3] Maisel, William H. "Semper Fidelis – Consumer Protection for Patients with Implanted Medical Devices." New England Journal of Medicine, 358, March 6, 2008. pp. 985-987. See also Steinbrook, Robert. "The Controversy over Guidant's Implantable Defibrillators." New England Journal of Medicine, 353, 2005. pp. 221-224.

[4] Avery, Sarah and Sabine Vollmer. "FDA ignored debris in syringes." The News & Observer (North Carolina), February 25, 2009. Baker, Mike. "FDA Didn't Inspect Syringe Plant Despite Reports." Associated Press, February 25, 2009. Jewett, Christina. "Could FDA Have Prevented Syringe Deaths?" ProPublica, February 26, 2009.

[5] "Is That Device Safe?" Editorial. The New York Times, January 26, 2009.

[6] Estimated Resources Required for Implementation. FDA Science and Mission at Risk: Report of the FDA Science Board's Subcommittee on Science and Technology. In response to the request of Representatives Dingell, Waxman, Stupak and Pallone. Submitted by Gail Cassell on behalf of the Subcommittee and its members. February 25, 2008. 11 pages. /022508.ScienceBoardReport.EstimatedResources.pdf

Starting with the base budget of $1.5 billion in fiscal year 2008, the recommended budget authority in millions (M) for each fiscal year are: $1,870M in 2009, $2,320M in 2010, $2,780M in 2011, $3,240M in 2012, $3,700M in 2013. For the full subcommittee report, see FDA Science and Mission at Risk. Report of the Subcommittee on Science and Technology, prepared for the FDA Science Board. November 2007. 60 pages plus Appendices.

[7] http://www.fda.gov/oc/oms/ofm/Budget/2009/BudgetTables/3_APT_TPL.pdf

The" class="redactor-autoparser-object">http://www.fda.gov/oc/oms/ofm/... figure of $550 million is for fiscal year 2008.

[8] Budget increases requested annually by the FDA are often, perhaps always, reduced in the final budget appropriation. For a vivid illustration of the cutback in increases requested during the period 1990 to 2001, see slide 7 ("History of FDA Budget Increase Requests FY 1990 – FY 2001") of a presentation by David W. Feigal, "Strengthening FDA...: Impact of Resources," at a George Washington University Policy Workshop, February 2007.

http://www.defendingscience.org/newsroom/upload/Feigal_Strengthening_FDA.pdf

Dr. Feigal was the Director of the FDA's Center for Devices and Radiological Health from 1999 to 2004.

[9] The letter to President Barack Obama on April 2, 2009, is posted at

http://finance.senate.gov/press/Gpress/2009/prg040209a.pdf

A similar letter to Congressman John Dingell on October 14, 2008, is posted at

http://energycommerce.house.gov/Press_110/110-ltr-101408.CDRHscientists.pdf

A similar letter to John Podesta (Obama transition team), on January 12, 2009, is posted at

http://www.thegraysheet.com/nr/FDC/SupportingDocs/gray/2009/011209_Lettr2transitionteam.pdf

[10] Mundy, Alicia. "Political Lobbying Drove FDA Process." The Wall Street Journal, March 6, 2009.

[11] Dr. Hamburg made this statement in a reply to a question by Senator Barbara Mikulski. A videocast of the hearing is posted at

http://help.senate.gov/Hearings/2009_05_07_b/2009_05_07_b.html